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Our Compounding Knowledge, Your Peace of Mind
July 26, 2019  |  Volume 16  |  Issue 30
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Pharmaceutical Compounding Questions and Answers

Question: Why is there a discrepancy between USP <797> and the BUDs provided in the official USP Compounding Monographs?

Answer:
Let’s look at both the chapter and the monographs to see what is presented.

USP <797>, Section 14.3 Establishing a BUD for a CSP states:

“Table 11 establishes the longest permitted BUDs for Category 2 CSPs.�

First, let’s look at the BUDs in Table 11:

For Aseptically processed CSPs sterility tested and not sterility tested, the maximum BUDs are:

Storage ConditionSterility TestedNot Sterility Tested
Controlled Room Temperature30 Days1 or 4 Days
Refrigerated Temperature45 Days4 or 10 Days

For Terminally sterilized CSPS sterility tested and not sterility tested, the maximum BUDs are:

Storage ConditionSterility TestedNot Sterility Tested
Controlled Room Temperature45 Days14 Days
Refrigerated Temperature60 Days28 Days

Second, let’s look at the BUDs (Days) in the official USP sterile compounding monographs:

PreparationRoom TemperatureRefrigerated Temperature
Cefazolin Ophthalmic Solution 5
Cisapride Compounded Injection, Veterinary 90
Cyclosporine Compounded Ophthalmic Solution, Veterinary 180
Dexamethasone Sodium Phosphate Compounded Injection 90
Fentanyl Citrate Compounded Injection 90 90
Fentanyl Citrate and Bupivacaine Hydrochloride Compounded Injection 90 90
Fentanyl Citrate and Ropivacaine Hydrochloride Compounded Injection 90 90
Guaifenesin Compounded Injection, Veterinary 90
Hydrochloric Acid Compounded Injection 120 120
Methylene Blue Injection, Veterinary 365
Morphine Sulfate Compounded Injection 90
Potassium Phosphates Compounded Injection 120
Sodium Phosphates Compounded Injection 120
Urea Compounded Irrigation 60 60
Voriconazole Compounded Ophthalmic Solution, Veterinary 60

Third, it appears that the above official USP formulations will be limited to the BUDs in Table 11 and pharmacists CANNOT use the BUD that is provided using stability-indicating analytical methods in the official USP compounding monograph.

Final Comment: This is another example of where USP <795>, <797>, and <800> are not all scientifically based and are inconsistent with each other.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

+++

REMINDER: For those State Boards of Pharmacy that are not adopting the USP chapters and are preparing their own or using their own modifications of the chapters, easily-modifiable alternative versions of Chapters <795>, <797>, and <800> have been prepared and are available as a free download for use by state boards of pharmacy to modify for their individual states at the following website.

      CompoundingToday.com

Also, you may wish to download these alternatives and send them to your state board of pharmacy for consideration. Also, send the following Sterile Compounding Consensus Statement, available at the same website.

Note: The Sterile Compounding Consensus Statement representing a digest of important changes found in the recently published final version of USP Chapter <797> has just been released, and is available on the Compounding Today website at: CompoundingToday.com

 

News

House Panel Claims Juul Targeted Schools, Camps, and Youth Programs
In hearings on youth vaping and Juul Labs, a House subcommittee asserted that the company targeted children and teenagers. Juul "deployed a sophisticated program to enter schools and convey its messaging directly to teenage children," recruited thousands of online influencers to market its vaping devices to youth, and targeted children as young as age 8 years in summer camp, according to a memo prepared by subcommittee staff members. Speaking before the panel, Juul co-founder James Monsees noted the company's decision last year to stop selling most of its flavored nicotine pods in stores and limit their availability to online, age-verified sales. The FDA threatened to remove the devices from the market if it did not take steps to keep them away from youth. The subcommittee's findings were based on thousands of documents obtained from Juul.
https://www.nytimes.com/2019/07/25/health/juul-teens-vaping.html

 

Did You Know ...

…the following regarding Common Sense (CS)?

Good health and good sense are two of life’s greatest blessings (Publius Syrus)

Ask advice, but use your own CS (Yiddish proverb)

Seldom are men blessed with good fortune and good sense at the same time (Latin proverb).

 

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Looking Back

Bristles scratched,
His cookie’s map,
That’s what made,
Poor Ginger snap!
     Burma-Shave

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